CAJ | 학술논문

目的：对Destiny Max全自动血凝分析系统（简称Desting Max）的主要性能指标进行评价。方法按照美国临床实验室标准化协会（CLSI）的相关文件对Destiny Max进行精密度、检出限、线性、携带污染率和试剂稳定性评价，并与 Stago STA-R血凝分析系统（简称 Stago STA-R）进行比较。评价项目为血浆凝血酶原时间（PT）、国际标准化比值（INR）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）及纤维蛋白原（FIB）。结果Destiny Max各检测项目批内精密度[变异系数（CV）]均＜3％，批间精密度（CV）均低于1/3总误差；FIB的检出限为0．50 g/L，在0．90～8．97 g/L范围内均有良好的线性；携带污染率均低于1/4总误差；试剂开瓶后在15 d内结果稳定，各检测项目CV均＜10％。Destiny Max与Stago STA-R相关性分析显示，除APTT相关系数（r2）为0．8134外，PT、INR、FIB的r2＞0．95，结果均呈高度相关。结论 Destiny Max精密度高，线性范围、检出限值、携带污染率达到要求，试剂稳定期长，性能稳定可靠，适合于各级医院临床应用。
목적：대Destiny Max전자동혈응분석계통（간칭Desting Max）적주요성능지표진행평개。방법안조미국림상실험실표준화협회（CLSI）적상관문건대Destiny Max진행정밀도、검출한、선성、휴대오염솔화시제은정성평개，병여 Stago STA-R혈응분석계통（간칭 Stago STA-R）진행비교。평개항목위혈장응혈매원시간（PT）、국제표준화비치（INR）、활화부분응혈활매시간（APTT）、응혈매시간（TT）급섬유단백원（FIB）。결과Destiny Max각검측항목비내정밀도[변이계수（CV）]균＜3％，비간정밀도（CV）균저우1/3총오차；FIB적검출한위0．50 g/L，재0．90～8．97 g/L범위내균유량호적선성；휴대오염솔균저우1/4총오차；시제개병후재15 d내결과은정，각검측항목CV균＜10％。Destiny Max여Stago STA-R상관성분석현시，제APTT상관계수（r2）위0．8134외，PT、INR、FIB적r2＞0．95，결과균정고도상관。결론 Destiny Max정밀도고，선성범위、검출한치、휴대오염솔체도요구，시제은정기장，성능은정가고，괄합우각급의원림상응용。
Objective To evaluate the main performance parameters of Destiny Max automatic coagulation analyzer (Destiny Max analyzer).Methods According to the Clinical and Laboratory Standards Institute (CLSI)document, the precision,detection limit,linearity,contamination rate and stability of Destiny Max analyzer were evaluated,and the results were compared with those by Stago STA-R coagulation system (Stago STA-R analyzer).The evaluation parameters included prothrombin time (PT),international standardization ratio (INR),activated partial thromboplastin time (APTT),thrombin time (TT)and fibrinogen (FIB).Results The within-run coefficients of variation (CV)of all the results detected by Destiny Max analyzer were <3%,and the between-run CV were <1/3 total error.The detection limit of FIB was 0.50 g/L,and it had good linearity in the range of 0.90-8.97 g/L.The results of contamination rate were less than 1/4 of total error.The results were stable within 15 d after open vial reconstituted.The CV of all the results were <10%.The correlation of Destiny Max analyzer,and Stago STA-R analyzer showed that except the coefficient of correlation (r2)of APTT was 0.813 4,the results of PT,INR and FIB were in high correlation (r2 >0.95).Conclusions The precision,linearity,detection limit and contamination rate of Destiny Max analyzer meet the requirements.The stability of reagents and performance of Destiny Max analyzer are quite good and suitable for the clinical application.